In another first for warning letters, complaint handling supplanted CAPA as the violation found most in letters. 1 Medical device manufacturers often struggle to keep up with complaint investigations ...

Annex IV (EC Declaration of Conformity – Full Quality Assurance System) of the IVDD (98/79/EC) is all about delineating specific regulatory requirement for devices falling under List A of Annex II.

An increasing number of medical devices incorporate artificial intelligence (AI) capabilities to support therapeutic and diagnostic applications. In spite of the risks connected with this innovative ...

While investments in healthcare innovation took a hit in the early months of the pandemic, an encouraging sign came in the third quarter of 2020 when private equity funds shifted from shoring up their ...

As has been widely noted, the COVID-19 pandemic has prompted countless people to rely on telehealth and virtual monitoring for their healthcare needs. This dramatic pivot is catalyzing a demand for ...

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR ...

Fabricio Pamplona, Ph.D., is the founder of Mind the Graph, an online platform that offers thousands of accurate medical illustrations that users can download. Pamplona has a background in ...

During the pandemic, OEMs and large suppliers of technology components required to launch new medical devices and sustain the lifecycles of existing products raised their prices to historic levels, ...

EU MDR required companies to make significant changes to their medical device labels, highlighting the need for a well-coordinated and agile device labeling process. We spoke with Laura Johnson, ...

Telemedicine has been aiding healthcare systems in delivering easy and convenient patient care for several years. However, it wasn’t until recently that the concept has exploded to a larger radius.

The global medical device industry is growing rapidly and poised for steady growth. According to the Facts and Factors market research report, the global medical devices market size and share revenue ...

Introduction: A Wake-Up Call from Recent History In the world of MedTech, traditional development processes often slow down innovation. Medical device manufacturers face an environment where global ...